Frequently Asked Questions

Clinical and Translational Research

Questions from applicants will be posted weekly along with answers from the Autism Council Staff.

1. Rolling over applications and addressing critiques:

Note: This FAQ refers to those applicants who applied to the previous Notice of Grant Availability (NOGA) for the Clinical Research or Translational Research Pilot Project grants and were not funded.

Q. I have rolled over my previously submitted application in SAGE and see that we have to reenter everything. Can we revise our original submission as we wish, or do we need to re-submit the same document exactly as before and separately address the critiques?

A. You'll want to revise your original application as you wish. It is considered a new application. You'll address the reviewers’ critiques in the “Response to Reviewer’s Critiques” box.

2. Percent effort of staff:

Q: Are there any guidelines in terms of % effort for the various positions such as PI, research associate, clinician, etc.?

A: The Grant Guidelines do not include specific guidance regarding the percent effort of the PI and other staff members to allow flexibility in the organization of the team. The final proposal will depend on the specific objectives of the program and the capability of the staff members. The specifics of the budget can be revised during the project period based on the evolving needs.

Q. Can I have a co-Principal Investigator?

A. The Principal Investigator is responsible for the execution of the project. Furthermore, the application is not structured to accommodate a co-Principal investigator, but a co-Principal Investigator (from a NJ research institution) can be listed in the key personnel and can be a subcontractor. The collaborator can be funded through a subcontract. Please note that the grant recipient must be a non-profit research entity in the State of New Jersey.

Q. I see that the new RFA still encourages collaboration with professionals outside of NJ who have special expertise. Can someone from outside NJ serve as a "Co-Principal Investigator with NJ-based PI, or would it be better if "Co-Investigator"?

A. Co-investigator is the correct designation for the out-of-state professional given that this is a grant funded by the NJ Department of Health. PIs and co-PIs are researchers with NJ research institutions.

3. IACC Objectives and NDAR

Q. I am writing to clarify what is being requested in section N. Resource Sharing Plan in the pilot grant applications. It is my understanding that we do not need to incorporate NDAR measures into our study if they are not compatible with the design of the study. Do we need to complete section N if we are not collecting NDAR measures? If yes, what should be included in this section?

A. Yes, you are correct in that the research pilot grants do not require the use of NDAR to share data. NDAR is just a mechanism to facilitate sharing. Section N. is where applicants can describe how they would share their data and other resources, as applicable, with other researchers.

You can respond to the section by saying that your
research design is not compatible with the collection of the data necessary for inclusion in NDAR. Then if you have plans to share data you can describe it in the section.

Q: What does the Council expect? What are their priorities/expectations?

A: The Council expects to fund strong pilot projects that address some of the outstanding questions in the field of autism and provide data to inform clinical practice. The objective is to improve the lives of patients with ASD. Meritorious research projects will need to 1) address one of the subset of IACC objectives listed in the Guidelines and 2) meet the NIH definitions for either clinical or translational research.

The subset of IACC objectives listed in the Guidelines were selected from the Interagency Autism Coordinating Committee (IACC) Strategic Plan (available online at http://iacc.hhs.gov/strategic-plan/2013/index.shtml and are those objectives with the potential to improve the physical and/or behavioral health and well-being of individuals with ASDs. The Council is particularly interested in projects with potential direct clinical impact.

Q: IACC objectives are so wide open - should we address more than one objective? Is it too narrow to pick just one objective?

A: The national priorities described in the Interagency Autism Coordinating Committee (IACC) Strategic Plan, and more specifically, the subset of IACC objectives applicable to this grant (listed in the Guidelines), represent the consensus of the experts in the field of ASD. Very few of these objectives can be met in a year. Successful projects will need to clearly articulate their research approach, and therefore are unlikely to be able to address more than one objective. While a research team with exceptional strengths in many areas and access to large numbers of patients could possibly propose a couple of small studies related to several objectives, it is not known whether the Council would ultimately choose to fund such a project over a focused project that provides strong conclusions related one IACC objective.

Q: Haven't these objectives already been done?

A: The IACC objectives are revised yearly, to reflect the evolving state of the science and public health needs. Most if not all of the IACC short- and long-term objectives will require data from more than one research project.

The yearly evaluation of the IACC strategic plan is based on an analysis of the existing grants portfolios. Detailed lists of funded projects and relevant programs are available at http://iacc.hhs.gov/portfolio-analysis/2010/index.shtml. The 2011-2012 IACC ASD Research Portfolio Analysis Report will be released in the near future.

Q: What are the advantages of using NDAR?

A: Pilot project grantees are strongly encouraged to use the National Database for Autism Research (NDAR) if compatible with the design of the projects. The New Jersey data will therefore be made available to autism researchers from around the United States, highlighting the New Jersey effort. Furthermore, participation in NDAR demonstrates that the funded projects are capable of meeting the National Institutes of Health (NIH) requirements and will help them develop stronger proposals for submission to the NIH and biomedical research foundations.

4. Staff included on more than one grant application

Q. Can the PI on one grant application be included on other grant applications (not as a PI on the other applications)?

A. Yes. However, no person can provide more than 100% effort across his/her projects.

5. Clinical research vs. clinical services

Q. Is this grant cycle meant for isolated research apart from the clinical work we do?

A. Yes, the grant program does not fund services for patients per se. The subjects involved in the research project will receive clinical care within the parameters set by the study. The Council expects to fund strong projects that address some of the outstanding questions in the field of autism and provide data to inform clinical practice. The objective is to improve the lives of patients with ASD.

Q. Our assumption is that the RFA is not looking for a service program, but clinical or translational research. Our project will involve diagnostic testing and treatment interventions, but not necessarily asking for funding for all of these. What can we utilize grant funds for?

A. The grant will only cover research expenses related to the specific research protocol. The use of funds from other sources is allowed and should be detailed in the application. The other sources of funds must be within the parameters set by the funding source, be fully disclosed and not duplicative.

Q. We are going through the requirements for the pilot clinical application and we do not see a specific place for information that would be in a clinical protocol such as inclusion/exclusion criteria etc. We are assuming that this information is to be placed in the "experimental design section" and that there is not a specific "clinical protocol" section. Is this correct?

A. Yes, you are correct.

6. Research subjects vs. patients

Q. When research subjects are recruited from a clinical center, do the clinical patients diagnosed with autism all need to be enrolled in the NDAR protocol with the minimal data requirements described in the grant?

A. Information about subjects involved in the research project will be shared via NDAR. Information about patients, who do not participate in the research project, should not be shared, even if they are treated at the same clinic.

Q. Can we use data collected for routine clinical care for which we are not asking for funding, for example for a control group?

A. Yes, it is acceptable to pay for part of the research project via other funds. A Principal Investigator can use data collected through routine medical care IF the patients have consented and the medical care is part of the established protocol. This should be made clear in the application.

Q. Do investigators need to have Collaborative Institutional Training Initiative (CITI) training or is the NIH webinar training for Protection of Human Subjects sufficient?

A. The NIH webinar training is sufficient.

Here is an excerpt from the state’s IRB policy:

All personnel engaged in Human Subjects research must have successfully completed an industry-standard program of Human Subjects Research Ethics Training within the past three (3) years and maintain such certification in current good standing for the duration of the research project. NJDHSS will accept certification of completion of the CITI or NIH/CDC courses as satisfying this requirement, and may, at its discretion accept certification from other recognized programs.

7. Responsibility for data analysis

Q. Is the Coordinating Center going to provide all the statistical and data analysis support? i.e. do applicants need to budget for it?

A. Grantees should expect to do their own data analysis. The Coordinating Center may help with sharing expertise across pilot projects. The Coordinating Center can provide statistical consulting. See the grant guidelines for the responsibilities of the Coordinating Center.

8. Budget

In general, there are no specific budgetary caps or restrictions, except that all requests must be necessary and justified for the grant. The SAGE application contains links to relevant Department of Health (DOH) policies.

Q. I did not see a section for budget justification in the RFA. Are the two sections, “Key Personnel” and “Experience” taking the place of a budget justification? If not where do I put the justification?

A. The justification for the first year budget is part of Schedules A-C in SAGE. As you complete each schedule you will need to complete the corresponding justification page(s). You don't need a justification for the year two budget if a general descriptions of how funding will be used in year two is included in the program plan (include in one of the narrative questions).

Q. Is there a cap on Principal Investigator’s (PI) Salary?

A. There is no cap on PI salary. Percent effort must be justified.

Q. Is there a cap on Travel each year?

A. Travel also must be justified. Travel to training sessions is the responsibility of the Coordinating Center.

Q. Are there restrictions on supplies/equipment such as computers, printers, etc.?

A. Supplies and equipment can be included only if they are necessary for the project. Applicants proposing to purchase equipment which will be used across multiple grants/programs should pro-rate the costs of the equipment across programs and show the calculation of this pro-ration in their justification. If an irregularity is found where equipment is being used by other programs without reimbursement, funding will be reduced accordingly.

Q. Are there restrictions on staff (i.e., admin staff, students, and postdocs)?

A. Administrative staff that will support the project can be included in the application. Students or postdocs would similarly need to be specifically working on the project. Applicants proposing to utilize the same principal investigator or contractual staff across multiple grants/programs should assure that the combined funding for each position does not exceed 100% FTE. If such an irregularity is found, funding will be reduced accordingly.

Note: Upon acceptance of a grant award, the applicant's organization assumes legal and financial responsibility for awarded funds and the conduct of supported activities. It is the responsibility of the applicant's institution and principal investigator to assure the accuracy and validity of all fiscal, scientific, and administrative information pertaining to the awarded grant. Failure to comply with these terms may result in grant termination.

Q. We plan for a two year pilot study. Can we divide the $400,000 unevenly between the two years with justification?

A. The budget can be no more than $200,000/year so you would have to budget evenly. If you don't use the $200,000 the first year it will roll over to the second year assuming Council approves continuation funding based on your progress report for the first year. If the $400,000 is not spent after year 2 you can request a no cost extension.

Q. For a Pilot Project for two years, it is up to $200K per year?

A. Yes, the Pilot Project grants are up to $200,000/yr., total of up to $400,000 for two year grants.

Q. Is there a limitation for budgeting purchase of a device for the project?

A. Supplies and equipment can be included only if they are necessary for the project. Applicants proposing to purchase equipment which will be used across multiple grants/programs should pro-rate the costs of the equipment across programs and show the calculation of this pro-ration in their justification. If an irregularity is found where equipment is being used by other programs without reimbursement, funding will be reduced accordingly.

9. Scoring the applications:

Q. How are the criteria for independent scientific review of the applications ranked/weighted? The criteria are specified in the Guidelines, but no weighting is mentioned.

A. The reviewers will assign to each application an overall impact score reflecting the potential impact on the field of autism and ultimately on New Jersey ASD patients and their families. The impact score will be based on NIH criteria. Scores range from 1 to 9 with 1 being the highest impact score.

The reviewers will consider the following core criteria in determining the overall impact score: significance, innovation, experimental design and capability, environment and key personnel. The overall potential impact of an application depends on both the importance and the feasibility of the proposed project. The significance and innovation core criteria will inform the importance of the project, whereas the other core criteria inform its feasibility.

Reviewers will also take into account the budget, yearly project objectives, the protection of human subjects, inclusion of women, children and minorities, the recruitment and community engagement plans and the resource sharing plan.
Each of the core criteria is scored and used to help the reviewers determine the overall impact score, but the criterion scores are not to be weighted explicitly. It is up to each reviewer to determine an overall score that best describes the likely overall impact that each application will have on the field of autism and ultimately on New Jersey ASD patients and their families.

The application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high impact score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move the field forward.

10. Miscellaneous

Q. In section "M. Experience:" How is "qualifications" being defined? Is it referring to certification or lic. etc.? If not how is it different than section "L. Key Personnel" "expertise"?

A. Experience refers to qualifications (credentials, experience) and time commitments as related to the proposed project. Key Personnel is asking for roles, responsibilities and expertise within the proposed project.

Q. Section K. “Environment” seems to be at least in part redundant to “Resources and Environment”, “Facilities”. Is the same information to be put in both places or are they asking for something different?

A. Environment is asking for a description of the overall environment beyond a list of facilities and equipment. Once you answer question "K" you'll be able to use some of the information to complete Resources and Environment and Facilities.

Q. Where is the statement about providing a letter from an institutional official indicating that there was support and space for the proposed work, such as a dept Chair, or a Dean of research?

A. On Page 27 of the RFA: a note at the end of K. Environment:

Note: Please attach a letter of support from a president, dean or other authority, as evidence of institutional support, labeled and attached as “Miscellaneous Attachments” in SAGE.

Autism Health Needs Medical Homes Pilot Project

Q. It is my understanding that the deliverables, such as the Project Charter, will be fully developed should funding be awarded. How much information do you need at this time regarding our plans for accomplishing the deliverables? For example, do we need to address every item in the Project Charter, A-K, or every aspect of the HIT Assessment, A-E?

A. In reference to Section C. (Proposal) in Appendix 7 every item of the six project requirements/deliverables does not have to be addressed separately. For example, applicants will describe the approach and plans for accomplishing Deliverable 1 (Project Charter). It would not be necessary to address each item (A-K under Project Charter in the Appendix 6 of the RFA) to show an understanding of the requirement.

However, in describing the approach and plans for accomplishing Deliverable 2 (HIT Assessment) applicants may find it advantageous to describe each item in confirming their understanding of the project requirement.

In addition to Section C. (Proposal), Sections D. (Organizational Capacity) and E. (Readiness to Implement) are very important in determining an applicant's ability to achieve the goals, objectives and deliverables of the project as well as the applicant’s readiness to design, develop, implement and measure all project requirements.

Q. 15 page proposal should include budget - does it need to include budget justification? (seems redundant, since justification needs to be included in SAGE budget).

A. The justification for the first year budget is part of Schedules A-C in SAGE. As you complete each schedule you will need to complete the corresponding justification page(s). You don't need a justification for the year two budget if a general descriptions of how funding will be used in year two is included in the proposal.

Q. Biosketch - I plan to include biosketches of PI and key staff. Is it necessary to include a biosketch of the clinical coordinator?

A. You should include the biographical sketch of the clinical coordinator if you describe the role of the person as a member of the core project management team (Appendix 7 of the RFA) section D (organizational capacity) as described below:

D. Organizational Capacity: a description of the applicant’s organizational capacity to achieve the goals, objectives, and deliverables of this RFA. The Applicant should describe core project management to execute the award, including the roles and responsibilities of project staff. The Applicant should identify its Project Manager’s ability to lead and manage the project to successful execution of the deliverables, monitor the project’s on-going progress; prepare and submit plans, reports, and performance measures; and facilitate communication with partners. The Applicant also should provide information about any contractual organization(s) that will have a significant role(s) in meeting the deliverables.

Q. Can the timeline with objectives, responsible staff and deliverables be an attachment since the Yearly objectives and responsible staff are already listed and there will be redundancy?

A. Just to clarify, the yearly objectives are included as the narrative in Part C (Proposal) in addition to “the steps planned to accomplish the objectives, the methods and the performance measures used to evaluate successful completion (i.e outcomes and deliverables)of the yearly objectives”.

The timeline should only include key activities/steps, responsible staff and deliverables. You don't need to repeat the yearly objectives in the timeline, only the steps to accomplish the objectives. Responsible staff should be included here. The point is to assess progress by assigning times based on completion of the activities/steps for each objective and ultimately the completion of the objective. There are many formats for timelines and most allow the reader to easily identify the times to completion of the activities/steps. It becomes a visual representation of the narrative.
The complete Proposal (Appendix 7-RFA) is submitted as a miscellaneous attachment in SAGE and the timeline can also be included as a miscellaneous attachment.

Q. The proposal is limited to 15 pages plus appendices. Is it within these 15 pages that all the components and deliverables should be contained?

A. All components listed in the Proposal Format (Appendix 7 of the RFA) must be included in the 15 pages plus appendices (graphs/charts).

To clarify, the proposal is Appendix 7. The applicant will describe the approach and plans for accomplishing the work and required deliverables (Project Charter, HIT System Assessment, Workflow Mapping, Action Plan, System Tools and Performance Deployment, Monitoring and Measurement) showing an understanding of the requirements (Appendix 6) and the ability to successfully complete the project requirements within the two year project period.

Applicants who are funded will complete the Project Requirements, with deliverables, (Appendix 6) within the two year grant period.

Q. We are discussing EHRs; however we do not have an EHR system. Are we required to have EHRs?

A. You are required to complete a HIT assessment and if you are discussing EHRs you should include the status of developing EHRs as one component of your core clinical system.

Q. The RFA refers to “children”. What age range is included?

A. From birth up to 22 years of age.

Q. Regarding the HIT part of the proposal: can some funding be used for creating an IT interface or web interface for means of sharing information between different partners in the project, since as yet there is not universal EHR? Does it have to all be already in place, or can funding be used to refine what might already be available?

A. Applicants are required to describe the approach and plans for accomplishing the HIT Assessment.

If awarded a grant, the grantee will assess its electronic infrastructure used to communicate and transfer patient information between physicians and other professionals, patients, programs and service agencies.

Q. Is the application format different from the research grants, where there are many different sections to complete?

A. Yes, the narrative format is different. Page 12 of the RFA: Autism Health Needs Medical Homes applicants must enter “NA” in each of the narrative boxes and attach the proposal (see Appendix 7 for required elements) with tables, charts and illustrations as “Miscellaneous Attachments”. All other forms in the SAGE application must be completed unless otherwise noted.

Q. To clarify, if applying for the medical home RFA, the only sections required in SAGE are A-F as listed on pg 34-35 of the RFA? No biosketches, required attachments, etc?

Q. Are we able to include IRB fees in our grant proposal budgets if we need to use a private IRB (for example Western IRB)?

A. Yes, IRB fees are an allowable expense.

SAGE

Q. It looks as though the biosketches in the Pilot Project application in SAGE have been condensed to one page only (no detail page). Is this correct?

A. Yes, that is correct. The additional support page includes questions that were previously included in the detail page.

Q. In the Pilot Project biosketch section in SAGE I see that there is a page for additional support. I am assuming I am inserting additional support for all of the key professional staff here. Am I reading this correctly?

A. You are correct - Individual one page biosketches and a single page with everyone’s additional support information.

Q. Under ‘Other Support’, my data is exceeding the approved length allotted and I am only up to my 4th person! Can the character length be increased?

A. The character limit cannot be increased for these applications. You can note at the end of the page that the remaining information is included as a miscellaneous attachment (include the name of the attachment).

Q. What are the budget period and project period for the projects in SAGE?

A. Both dates are June 29, 2015 to June 30, 2017.

Q. When I open the SAGE program Autism Pilot Project 2015 I see a combination of letters and numbers that I’m not familiar with, as the Account reference.

A. This is a SAGE generated number. You are in the correct program for the Autism Pilot Project application.

Q. Can we add the CV's as an attachment vs. filling in the CV grid page on SAGE?

A. The CV grid page on SAGE needs to be filled in. If you need additional space you can attach as a miscellaneous.

Q. Will reviewers access the grant electronically or printed copy (we have graphics which show up differently electronically vs. print).

A. Reviewers will have access electronically. In addition to completing the narrative questions on SAGE (clinical and translational research) we recommend attaching a complete narrative with graphics, charts etc. as a miscellaneous attachment.

Q. Is a Tax Clearance Certificate a new requirement?

A. The requirement was effective July 1, 2012. All contracted agencies are required to complete an Application for Tax Clearance—Business Assistance and Incentives http://www.state.nj.us/treasury/taxation/busasst.shtml. A Tax Clearance Certificate will be uploaded to SAGE as a Required Attachment during the application process. Tax Clearance Certificates must be acquired before the application submission due date. Failure to acquire the Tax Clearance Certificate will make the application Non-Responsive. Additionally, a Statement of Gross Revenue or Annual Audit Report is required.